Malyugin Ring System 7.0mm MAL-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10844685000040), received between Jul 24, 2023 and Jul 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  THE MALYUGIN RING HAS 4 SCROLLS (EYLETS) THAT HOOK ONTO IRIS. DURING THE CASE THE SURGEON REPORTED AN EYELET WAS PREVIOUSLY FUSED, WOULD NOT ENGAGE AND BENT TOWARD THE CENTER. AFTER SEVERAL ATTEMPTS OF TRYING TO ENGAGE, IT WAS REMOVED AND REPLACED BY ANOTHER MALYUGIN RING. AFTER THE CASE, THE EYLET WAS FOUND DEFECTIVE. CORNEAL EDEMA CAUSED BY DISRUPTING ENDO AND DESCEMETS WAS REPORTED. STEROIDS WERE PRESCRIBED TO TREAT THE PATIENT. FULL PATIENT RECOVERY REPORTED.

  Patient problems: Corneal Edema

  MAUDE report 17403090 ↗
• MalfunctionJul 24, 2023Failure to Eject; Failure to Eject

  IT WAS REPORTED THE RETRACTOR FAILED TO OPEN PROPERLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376098 ↗